Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic.

Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic: A Randomized Control Trial.

Sepsis is an inflammation response produced by the host's immune system, which is agrravated by oxidative stress. One of the adjuvant therapy according to Surviving Sepsis Campaign Guideline is albumin, which has anti-inflammatory and anti-oxidant effects. However, human albumin is quite expensive, and other forms with similar potency and less costs are needed, one of which is Channa striata extract. Therefore, this study is conducted to compare albumin and human albumin, specifically their anti- inflammatory and anti-oxidant properties by assessing the eNOS marker, neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio (PLR) in patient with sepsis.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Dietary supplement: Albumin Channa Striata Extract

Detailed Description

In summary, this study showed that Channa striata extract has a better outcome in stabilizing eNOS level in patient with sepsis than human albumin 20%, and it has a potential benefit in stabilizing NLR values. However, further studies with a larger sample and a more advanced phase of sepsis are needed.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Central Jave
    • Sukoharjo, Central Jave, Indonesia, 57126
      • Moewardi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients sepsis who met the qSOFA criteria ≧ 2 [two of which: unconsciousness (Glasgow Coma Scale ≤14)
• respiratory rate > 22 and systolic blood pressure ≤ 100 mmHg],
• aged ≧ 18 years
• admitted to intensive care unit and high care unit at Dr. Moewardi General Hospital

Exclusion Criteria:

• patients with severe trauma
• blood loss in stage three or higher
• stress ulcers
• a history of nephrotic syndrome
• refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Albumin Chana Striata Extract	Dietary supplement: Albumin Channa Striata Extract; This study is a randomized controlled trial of 42 patients at the ICU of Dr. Moewardi General Hospital. The control group received 20 grams of human albumin on the first day and the study group received 15 grams of Channa striata extract daily for two days. Subsequently, eNOS, NLR and PLR are measured before and three days after treatment, and the examiners compare the three markers statistically.; Other Names: Human Albumin
ACTIVE_COMPARATOR: Human Albumin	Dietary supplement: Albumin Channa Striata Extract; This study is a randomized controlled trial of 42 patients at the ICU of Dr. Moewardi General Hospital. The control group received 20 grams of human albumin on the first day and the study group received 15 grams of Channa striata extract daily for two days. Subsequently, eNOS, NLR and PLR are measured before and three days after treatment, and the examiners compare the three markers statistically.; Other Names: Human Albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Nitric Oxide Synthase	Measured before and three days after treatment, and the examiners compare the three markers statistically.	three days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil-Lymphocyte Ratio	Measured before and three days after treatment, and the examiners compare the three markers statistically	three days after treatment
Platelet-Lymphocyte Ratio	Measured before and three days after treatment, and the examiners compare the three markers statistically	three days after treatment

Collaborators and Investigators

• Sponsor: Universitas Sebelas Maret

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): September 30, 2021

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (ACTUAL): October 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: albumin; inflammation; sepsis; PLR; anti-oxidant; NLR; eNOS; Channa striata
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: Septian Adi P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No